Safety of Autologous M2 Macrophage in Treatment of Non-Acute Stroke Patients

Recruiting

Phase 1 Results N/A

Trial Description

The purpose of this study is to determine whether M2 macrophages are safe and feasible in the treatment of non-acute stroke patients

Detailed Description

Our primary hypothesis is that autologous M2 macrophage transplantation via intrathecal introduction is feasible and safe after non-acute stroke. Our secondary hypothesis is that autologous M2 macrophage transplantation is associated with improved neurological outcome after non-acute stroke

Conditions

Interventions

  • M2 macrophage introduction Other
    Intervention Desc: Generation of autologous M2 macrophages from peripheral blood of non-acute stroke patients Intrathecal introduction of autologous M2 macrophages
    ARM 1: Kind: Experimental
    Label: M2 macrophages
    Description: M2 macrophage introduction

Trial Design

  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary The number of patients with severe adverse events 1-3 days, 6 months Yes
Secondary Improvement of functional outcome in National Institutes of Health Stroke Scale (NIHSS) 1-3 days, 6 months No
Secondary Improvement in Barthel Index 1-3 days, 6 months No
Secondary Improvement in modified Rankin scale 1-3 days, 6 months No

Sponsors